JJY · Class I · 21 CFR 862.1660

FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)

Leading manufacturers include Bio-Rad, Medical Analysis Systems, Inc. and Cliniqa Corporation.

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
337–360 of 673
Cleared Dec 27, 1989
NORMAL AND ABNORMAL CONTROL SERA
K895943
Sclavo, Inc.
Chemistry · 77d
Cleared Sep 28, 1989
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
K894852
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Aug 11, 1989
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
K894078
Bio-Rad
Chemistry · 56d
Cleared Aug 01, 1989
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
K894252
Bio-Rad
Immunology · 42d
Cleared Jul 20, 1989
DADE LIPID-TROL
K893580
Baxter Healthcare Corp
Chemistry · 72d
Cleared Jun 23, 1989
DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET
K893141
Casco Standards
Chemistry · 59d
Cleared Jun 23, 1989
DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET
K893142
Casco Standards
Chemistry · 59d
Cleared Jun 13, 1989
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
K891680
Bio-Rad
Immunology · 84d
Cleared May 09, 1989
MONI-TROL(R)
K891929
Baxter Healthcare Corp
Immunology · 42d
Cleared Mar 20, 1989
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)
K890708
Amersham Corp.
Chemistry · 48d
Cleared Mar 15, 1989
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)
K890414
Amersham Corp.
Chemistry · 50d
Cleared Mar 15, 1989
RIATRAC PLUS
K890470
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 43d
Cleared Nov 10, 1988
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
K883942
Icl Scientific
Toxicology · 52d
Cleared Oct 25, 1988
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
K882486
Bio-Rad
Chemistry · 131d
Cleared Oct 13, 1988
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST
K883861
Casco Standards
Chemistry · 30d
Cleared Oct 11, 1988
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA
K882736
Amersham Corp.
Chemistry · 102d
Cleared Oct 06, 1988
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190
K882728
Amersham Corp.
Chemistry · 97d
Cleared Sep 30, 1988
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K883124
Amersham Corp.
Chemistry · 66d
Cleared Aug 08, 1988
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
K882727
Amersham Corp.
Chemistry · 38d
Cleared Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542
Bio-Rad
Chemistry · 30d
Cleared Jul 08, 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503
Baxter Healthcare Corp
Chemistry · 88d
Cleared Jul 06, 1988
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
K881437
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 06, 1988
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
K881438
Hichem Diagnostics
Chemistry · 92d
Cleared Jun 02, 1988
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS
K881436
Hichem Diagnostics
Chemistry · 58d